[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hematological-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hematological-tumor":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100596318","phase-2-romiplostim-n01-for-chemotherapy-induced-thrombocytopenia-in-pediatric-cancer-patients-100596318",false,"NCT07043894","Romiplostim N01 for Chemotherapy-Induced Thrombocytopenia in Pediatric Cancer Patients","A Prospective, Multicenter Study on the Efficacy and Safety of Romiplostim N01 for Chemotherapy-Induced Thrombocytopenia (CIT) in Children, Adolescents, and Young Adults (CAYA) With Hematological and Solid Tumors","Inclusion Criteria:\n\n1. Voluntary participation with signed informed consent.\n2. Aged 6-24 years, any gender.\n3. ECOG performance status 0-2.\n4. Histologically\u002Fcytologically confirmed non-myeloid malignancy requiring high-intensity chemotherapy with ≥1 myelosuppressive agent.\n5. Patients with potential curative opportunity eligible for standard therapy.\n6. Chemotherapy-induced thrombocytopenia (platelets \\\u003C75×10⁹\u002FL).\n7. Anticipated survival ≥8 months.\n8. Planned ≥2 additional chemotherapy cycles (21-\u002F28-day cycles).\n9. Laboratory parameters meeting:\n\n   * Renal function: Cr ≤1.5×ULN; Ccr ≥55 mL\u002Fmin.\n   * Hepatic function:\n\n     * Total bilirubin ≤1.5×ULN; ALT\u002FAST ≤3×ULN;\n     * For liver metastasis\u002Fcholangiocarcinoma: bilirubin ≤3×ULN, transaminases ≤5×ULN.\n10. No participation in other drug trials within 4 weeks.\n11. Good compliance with efficacy\u002Fsafety follow-up per protocol.\n12. Absence of severe complications (e.g., active GI bleeding\u002Fperforation, jaundice, obstruction, non-cancer fever \\>38°C).\n13. Ability to comprehend and sign informed consent.\n\nExclusion Criteria:\n\n1. Hematologic disorders (non-CIT etiology): AML, ITP, MDS, MPN, multiple myeloma, etc.\n2. Non-CIT thrombocytopenia within 6 months (e.g., chronic liver disease, hypersplenism, infection, hemorrhage).\n3. Known hypersensitivity to romiplostim N01 or excipients (cellulose-lactose, L-HPC, magnesium stearate, film coating).\n4. Refractory cytopenias:\n\n   * Hemoglobin \\\u003C50 g\u002FL despite RBC\u002FEPO;\n   * ANC \\\u003C1.0×10⁹\u002FL despite G-CSF.\n5. Pelvic\u002Fspinal\u002Flarge-field radiotherapy within 3 months.\n6. Arterial\u002Fvenous thrombosis within 3 months.\n7. Severe cardiovascular disease (NYHA Class III-IV, arrhythmia with thromboembolic risk, post-CABG\u002Fstent) within 6 months.\n8. Use of rhTPO, rhIL-11, or TPO-RAs (eltrombopag\u002Favatrombopag\u002Fhetrombopag) within 2 weeks.\n9. Investigator-assessed risks compromising safety\u002Fefficacy evaluation.","ALL","6 Years","24 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to evaluate the efficacy and safety of romiplostim N01 in treating chemotherapy-induced thrombocytopenia (CIT) in children and adolescents\u002Fyoung adults (CAYA; aged 6-24 years) with hematologic malignancies or solid tumors. The main questions it aims to answer are:\n\n* What proportion of participants achieve platelet count recovery (≥100×10⁹\u002FL or an increase of ≥30×10⁹\u002FL from baseline) within 3 weeks of romiplostim N01 treatment?\n* What is the safety profile of romiplostim N01 in this population, including the incidence and severity of adverse events (especially bleeding and thrombosis)? This is a single-arm study (no comparison group). Researchers will assess the outcomes against predefined efficacy thresholds and historical data (e.g., a 60.7% response rate reported for another TPO-RA, hetrombopag).\n\nParticipants will:\n\n* Receive weekly subcutaneous injections of romiplostim N01 (starting dose: 2 µg\u002Fkg).\n* Have their romiplostim dose adjusted weekly based on platelet counts (increase by 1-2 µg\u002Fkg if platelets \\\u003C99×10⁹\u002FL, maximum dose 10 µg\u002Fkg, stop when target recovery is met).\n* Undergo frequent monitoring, including blood tests (especially platelet counts), vital signs, physical exams, and assessment for adverse events and bleeding throughout the treatment and follow-up period.",[27,28,29,30,31],"Solid Tumors","Hematological Tumor","Children","Adolescent","Chemotherapy Induced Thrombocytopenia","RECRUITING","2026-05-06",{"date":35,"type":36},"2026-05-07","ACTUAL",{"date":38,"type":36},"2025-12-25",{"date":40,"type":21},"2026-09-01",{"name":42,"class":43},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER"]